Many surgeries performed today are considered to be routine, with complication rates that are generally low and where problems related to anatomy seldom arise. However, certain surgeries subject the patient to a greater level of risk and involve procedures that are made more complex by the presence of tortuous and difficult to treat anatomy. Neurological, coronary, and thoracic vascular procedures fall into this category due to the sensitive areas involved, but some of the complications simply involve an inability to reach the target vasculature. Difficulty in reaching the target site in these cases leads to a longer procedure, since the surgeon must find the most suitable approaches and instrumentation to use on a particular patient's anatomy by trial and error. Extending the length of the procedure greatly increases the probability of adverse surgical events, including death. Unfortunately, standard equipment and procedures are not available in these cases because of patient-to patient anatomical variability.
During the training of any medical professional, science, or pre-medical student, hands-on training is essential. The standard for such training has been the use of human cadavers, which are expensive and difficult to obtain. Also, the risks associated with the use of human cadavers including risks relating to the exposure to biohazards, for example, formaldehyde presents a disadvantage of using human cadavers for training purposes. Furthermore, cadaver models provide a fairly accurate representation of size and geometry, but the mechanical properties of the target anatomy are altered by death of the subject and by the required tissue preservation techniques. It is therefore impossible to use these models at normal body temperature or in the presence of fluids.
Animals are also often used for training purposes in the scientific and medical fields; however animal models suffer from a whole range of unique problems, including the many deviations between human and animal anatomy and physiology, the confounding effects of variation between individual animals, and the unpredictability that arises from using a model that is extraordinarily complex.
Animal models may include live canine, porcine, or bovine specimens, among others. While these animals do offer an in vivo environment, their anatomy and physiology differs significantly from that of a human. The specialized facilities required to house the animals and the expenses associated therewith limit their in-house use. Reproducibility may also be an issue as both inter- and intrasubject variability are difficult to control. Additional considerations include contention with the Animal Welfare Act, the significant expense associated with contracting regulated facilities and medical practitioners, and the risks related to handling biohazardous materials.
Human anatomical models have been proposed using elastomeric compositions for human tissue. However, there has not been a model training device that includes the necessary level of detail and similarity to a human body, including the finer aspects of human tissue, and the functionality of systems of the human body necessary for effective training. Difficulty has been found in the prior art in replicating human tissue at a level at which the final product bears sufficient similarity and functions in a way that is nearly parallel to that of the human body.